Statistical Programmer

Responsibilities

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs in accordance with CDISC standards
• Support statistical analyses for safety reports, publications, CSRs, and regulatory submissions
• Ensure programming activities comply with FDA 21 CFR Part 11, GxP, and internal SOPs
• Collaborate with biostatisticians and data managers to define analysis specifications
• Perform quality control and detailed review of statistical programs and outputs
• Develop reusable macros, templates, and automation tools to improve efficiency
• Contribute to the implementation of emerging technologies, including AI-based tools, to enhance workflows

Requirements

• Master’s degree in a quantitative field with 5+ years of industry experience, or Bachelor’s degree with 8+ years of experience
• Strong proficiency in SAS and/or R for clinical trial data analysis
• Working knowledge of CDISC standards (SDTM, ADaM, Define-XML)
• Experience producing TLFs and datasets in pharmaceutical, biotech, or CRO settings
• Experience with oncology clinical trials or cell/gene therapy programs
• Familiarity with regulatory guidelines (FDA, ICH) and GxP practices

Preferred Qualifications

• Hands-on experience developing AI agents or applying AI/ML-based automation tools
• Experience supporting regulatory submissions (NDA, BLA, MAA)
• Familiarity with electronic submission standards (eCTD)

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer.